Alembic Pharma receives USFDA tentative approval for Bosutinib Tablets

Alembic Pharmaceuticals announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib Tablets, 400 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Bosulif Tablets, 400 mg, of PF Prism C.V. Bosutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic-phase Philadelphia chromosome?positive (Ph+) chronic myelogenous leukemia (CML), including newly diagnosed patients as well as those resistant or intolerant to prior therapy. It is also indicated for adult patients with accelerated- or blast-phase Ph+ CML who are resistant or intolerant to earlier treatment.

Alembic had earlier received final approvals for Bosutinib Tablets in 100 mg and 500 mg strengths. The 400 mg strength has an estimated market size of about $251 million for the 12 months ended September 2025, according to IQVIA.

With this approval, Alembic?s cumulative ANDA approvals from the USFDA stand at 232, comprising 212 final approvals and 20 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company engaged in the manufacture and marketing of generic pharmaceutical products across global markets.

The company?s consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in Q2 September 2025.

Shares of Alembic Pharmaceuticals shed 0.51% to Rs 795.80 on the BSE.

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